Evaluation of solid-state thermal stability of donepezil in binary mixtures with excipients using instrumental techniques

Ledeți, Ionuț; Bolintineanu, Sorin; Vlase, Gabriela; Circioban, Denisa; Dehelean, Cristina; Suta, Lenuta-Maria; Caunii, Angelica; Ledeţi, Adriana; Vlase, Titus; Murariu, Marius

doi:10.1007/s10973-017-6250-3

Cited by 8 publications

(3 citation statements)

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“…The summarization of thermoanalytical data is presented in Table 3. In previous papers, we also carried out diffractometric (XRPD) studies on binary mixtures kept under ambient conditions, when the corroboration of thermoanalytical data with the ones suggested by the FTIR spectroscopy were not concluding [23,25,26,35,39]. However, in the case of LTSS mixtures with selected excipients, no discrepancies were noticed between the selected instrumental techniques, as the incompatibilities suggested by the FTIR study were confirmed by the thermal analysis.…”

Section: Thermal Stability Investigationsmentioning

confidence: 99%

“…There were selected a number of solid excipients, having different properties and playing various roles into the final formulation. The following excipients were included: starch, anhydrous lactose, D-mannitol, D-sorbitol, gelatin, calcium lactate pentahydrate, magnesium stearate, methyl 2-hydroxyethyl cellulose (Tylose), colloidal SiO 2 (Aerosil) and talc, while, as instrumental techniques, UATR-FTIR spectroscopy and thermoanalytical tools were chosen, by a methodology previously reported in the literature [23][24][25][26][27][28][29][30][31].…”

Section: Concordet Et Al Reported In March 2017 a New Formulatimentioning

confidence: 99%

“…It is well known that magnesium stearate (MgSt) is an excipient that commonly shows interactions to various APIs [25,39]. Surprisingly, in the case of the LTSS+MgSt mixture, interaction is not observed.…”

Section: Thermal Stability Investigationsmentioning

confidence: 99%

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Stability and Compatibility Studies of Levothyroxine Sodium in Solid Binary Systems—Instrumental Screening

et al. 2020

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The influence of excipients on the stability of sodium levothyroxine pentahydrate (LTSS) under ambient conditions and thermal stress was evaluated. Since LTSS is a synthetic hormone with a narrow therapeutic index, the interactions of LTSS with excipients can lead to a drastic diminution of therapeutic activity. Ten commonly used pharmaceutical excipients with different roles in solid formulations were chosen as components for binary mixtures containing LTSS, namely, starch, anhydrous lactose, D-mannitol, D-sorbitol, gelatin, calcium lactate pentahydrate, magnesium stearate, methyl 2-hydroxyethyl cellulose (Tylose), colloidal SiO2 (Aerosil) and talc. As investigational tools, universal attenuated total reflectance- Fourier transform infrared spectroscopy UATR-FTIR spectroscopy and thermal analysis were chosen and used as follows: UATR-FTIR spectra were drawn up for samples kept under ambient conditions, while thermoanalytical tools (TG/DTG/HF data) were chosen to evaluate the inducing of interactions during thermal stress. The corroboration of instrumental results led to the conclusion that LTSS is incompatible with lactose, mannitol and sorbitol, and these excipients should not be considered in the development of new generic solid formulations.

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